Kornimate/medical-research-clean huggingface dataset:
specific clinical experience investigation for long-term use of bydureon.

Conditions: Type 2 Diabetes

Summary: to confirm the safety and efficacy of bydureon in long-term use in japanese patients with type 2 diabetes mellitus under actual drug use.

to confirm the safety and efficacy of bydureon (hereinafter referred to as bydureon) in long-term use in japanese patients with type 2 diabetes mellitus under actual drug use. 1. primary objective to confirm the safety profile in japanese patients with type 2 diabetes mellitus receiving bydureon under daily practices. 2. secondary objective as the secondary objective of this s-cei, the following items are to be investigated. * frequencies of aes related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction. * development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy) * safety in patients with mild or moderate renal impairment * changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, hba1c, and blood lipids * bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, bydureon administration, etc) * anti-exenatide antibody titer in ae cases (hypersensitivity, loss of control of blood sugar)

Eligibility criteria:
inclusion criteria: - the patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise. exclusion criteria: * no past history of hypersensitivity to the components of bydureon. * not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus. * bydureon will not be administered to the patient in an emergency situation such as severe infection and operation. * not the patient with severe renal impairment, including those receiving dialysis.

Keywords: diabetes mellitus(dm) bydureon exenatide
duplication in chit1 gene and the risk for aspergillus lung disease in cf patients

Conditions: Cystic Fibrosis; Chit1

Summary: title: duplication in chitotriosidase (chit1) gene and the risk for aspergillus lung disease in cf patients. aim: to evaluate the link between chit1 duplication in cf patients and the predisposition to abpa or persistent aspergillus infection. patients: 40 cf patients. design: observational, single visit. methods: all patients will be assessed for pulmonary function tests (pft), sputum cultures, and blood tests for: chit1 duplication, immunoglobulin e (ige) and eosinophils levels. part of the patients will be assessed for rast, skin prick test. primary outcome measure is the difference in chit1 genotyping between the groups.

title: duplication in chitotriosidase (chit1) gene and the risk for aspergillus lung disease in cf patients. introduction: chitinases are the enzymes that digest the chitin polymer. plants use chit1 as an important innate defense mechanism against fungi. chit1 is the major chitinase in the human airways.variation in the coding region, with 24-bp duplication allele results in a reduced chit1 activity. recently, chit1 duplication was found in 6/6 patients with severe asthma and fungal sensitization aspergillus often persists in the respiratory tract of patients with cystic fibrosis (cf) and may cause allergic broncho pulmonary aspergillosis (abpa). aim: to evaluate the link between chit1 duplication in cf patients and the predisposition to abpa or persistent aspergillus infection. patients: 40 cf patients divided to three groups .group 1: patients who have neither abpa nor aspergillus infection in the past (the control group).group 2: patients with persistent aspergillus infection, without abpa. group 3: patients with current or past abpa. design: observational, single visit. methods: all patients will be assessed for pulmonary function tests (pft), sputum cultures, and blood tests for: chit1 duplication, ige and eosinophils levels. patient's characteristics including demographics, cf mutations, pancreatic status and sweat test will be derived from the charts. patients with abpa as well as aspergillus infection had also radioallergosorbent test (rast) for molds, as well as skin prick test for aspergillus and blood galactomannan. the primary outcome measure is the difference in chit1 genotyping between the groups.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystic fibrosis. exclusion criteria: * inability to produce sputum, or previous history of lung transplantation.

Keywords: chit1 cystic fibrosis allergic bronchopulmonary aspergillosis (abpa) aspergillus
pilot study of biomarkers of response to immune checkpoint blockade in metastatic melanoma

Conditions: Melanoma

Summary: this study uses molecular imaging and novel immune monitoring to identify a biomarker of response for melanoma patients receiving immunotherapy with anti-pd-1 immunotherapy. prior to treatment, fdg and flt pet/ct will be obtained, together with blood and tumor biopsies from each patient. a follow-up fdg and flt pet/ct will be obtained, together with blood and tumor biopsies, 10-12 weeks after starting treatment with anti-pd-1 antibody. additional tumor biopsies and blood samples for immune monitoring will be obtained 4-6 weeks after starting treatment with anti-pd-1 antibody as well as 16-18 weeks after starting anti-pd-1 treatment for patients still receiving anti-pd-1 antibody at that time.


Eligibility criteria:
inclusion criteria: * participants must have a metastatic melanoma diagnosis (stage iv) for which treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies, is planned. no additional laboratory testing is needed for the imaging in this study apart from the standard laboratory testing routinely obtained for treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies. * participants must have at least 2 subcutaneous or lymph node melanoma metastases that are 2 cm in greatest diameter and are amenable to being biopsied in clinic without requiring image-guidance. * participants must be able to provide informed consent * women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study. exclusion criteria: * not able to receive treatment with either nivolumab or pembrolizumab. * women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of the first study flt pet/ct and must not be breast feeding for the duration of study participation.

Keywords: melanoma antimelanoma t cells
effect of education and tele-consultancy intervention based on watson human care theory individuals with copd

Conditions: Chronic Obstructive Pulmonary Disease; Self Efficacy; Quality of Life; Pulmonary Function; Nurse's Role

Summary: this study aims to investigate the effect of education and tele-consultancy intervention based on watson's human care theory on self-efficacy and quality of life of individuals with copd.

: the research that a single-blinded randomized controlled trial, a total of 74 individuals, including 37 individual intervention and 37 individual control groups who applied to akdeniz university chest diseases polyclinic for consultation and follow-up, meeting the inclusion criteria, conducted between october 2020 - may 2022. in collecting data information form based on watson human care theory, the chronic obstructive pulmonary disease self-efficacy scale, st. george quality of life scale, and pulmonary function test form were used. individuals in the intervention group were provided with training and consultancy based on watson human care theory, and an educational booklet prepared with current guides and expert opinions. telephone counseling was provided in the 2nd, 4th, 6th, 8th, and 10th weeks after the first intervention in the intervention group. routine follow-up of individuals in the control group was continued. the data of the scales in the intervention and control groups are collected in the 12th week. the individuals in the control group were given a training booklet at the end of the study. statistical analysis of the data was done with spss 22.0 software package.

Eligibility criteria:
inclusion criteria: * who has been diagnosed with copd for more than 6 months * no exacerbation for at least 4 weeks, stable period * followed up at akdeniz university hospital chest diseases polyclinic * clear conscious (evaluated by sandartize mini-mental test higher than 23 points) * no verbal communication barriers * individual phone owner * no hearing or communication problems on the phone * 18 years and older * literate * agree to participate in the research exclusion criteria: * not getting enough points from the standardized mini-mental test * a diagnosis of malignancy (based on file information)

Keywords: chronic obstructive pulmonary disease nursing quality of life self-efficacy watson's human care theory
anatomical feasibility of the off-the-shelf e-nside multibranch stent graft system for thoracoabdominal and para-renal aortic aneurysms.(e-nside study)

Conditions: Aortic Aneurysm, Thoracoabdominal; Para-renal Aortic Aneurysms

Summary: the study was created to evaluate the theoretical anatomical feasibility of the new e-nside multibranch stent graft system (jotec gmbh, hechingen) in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated with other techniques for this pathology in the vascular unit of san raffaele hospital, in the past ten years. with this study, investigators want to analyze in how many cases the new prosthesis would be usable. e-nside multibranch stent graft system (jotec gmbh, hechingen) is in the pre-ce marking stage. at present, the certifying organism is evaluating the documentation for the release the ce mark certification and declaration of conformity.


Eligibility criteria:
inclusion criteria: - patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at san raffaele hospital between january 2007 and january 2017. exclusion criteria: - incomplete or inappropriate imaging quality defined as pre-operative ctas with slice thickness \>1-mm.
determining the lymphokine activated killer (lak) cytotoxicity present in patients undergoing interleukin-2 therapy

Conditions: Melanoma; Kidney Cancer

Summary: therapy with interleukin-2 stimulates lymphocytes in humans to become lymphokine-activated killer cells (lak). this study will determine if these killer cells are able to kill certain standard cell-lines in the laboratory.

blood samples will be taken from patients undergoing outpatient interleukin-2 therapy to measure the lak cytotoxicity at baseline, after 1 cycle of therapy and 2 months later. the lak cytotoxicity assay will be a standard colorimetric assay that measures lactic dehydrogenase release from lysed cells.

Eligibility criteria:
inclusion criteria: * patients must be undergoing interleukin-2 therapy under the care of physicians at loma linda university cancer center * patients must sign and give written informed consent in accordance with institutional and federal guidelines exclusion criteria: * patients not undergoing interleukin-2 therapy under the care of physicians at loma linda university cancer center

Keywords: interleukin-2 melanoma kidney cancer lymphokine activated killer cells
the effect of da9301 on tablet computer-induced asthenopia

Conditions: Asthenopia

Summary: asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from intensive work. vaccinium uliginosum is a flowering plant in the genus vaccinium. this plant is native to cool temperature regions of the northern hemisphere. considering its antioxidative ingredients, the extract of vaccinium uliginosum is expected to play a significant role in treating various ocular pathologies. the investigators performed a randomized, case-controlled study in healthy subjects and investigated the protective effect of vaccinium uliginosum extract (da-9301) on tablet computer-induced asthenopia.


Eligibility criteria:
inclusion criteria: 1. healthy subject aged 20 to 65 years with more than 2 hours of daily use of a smart phone or computer including a tablet and television exclusion criteria: 1. ocular disease in either eye * ocular surface disease * best corrected visual acuity \< 20/30 * intraocular pressure \> 21 mmhg * optical coherence tomography proven retinal nerve fiber defect * significant cataract (lens opacities classification system iii) * significant entropion or ectropion * significant tear drainage problem proved with fluorescein dye dilution test 2. soft or hard contact lens use 3 or more days a week 3. history of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study 4. pregnant woman 5. systemic disease * uncontrolled hypertension (systolic /diastolic blood pressure \> 140/90mmhg) * uncontrolled diabetes mellitus (fasting blood glucose level \> 180mg/dl) * rheumatoid arthritis * malignant disease * active hepatitis (type b and c) * acute or chronic infectious disease * renal disease
treatment with fixture microthread™ in patients with poor bone quality and no teeth in the upper jaw, when using two-stage surgery

Conditions: Jaw, Edentulous; Poor Bone Quality

Summary: the primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with fixture microthread™ (micro-macro). clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. this was a result of feedback regarding the subjective feeling during the installation procedure. there were no safety concerns w/r to the study products. patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.


Eligibility criteria:
inclusion criteria: * 18 - 75 years of age * bone quality class iii or iv, (according to lekholm \& zarb16) * willing to give signed informed consent exclusion criteria: * need for bone augmentation of the maxilla * tobacco smoking more than 5 cigarettes/day * any systemic disease or condition that would compromise post-operative healing and/or osseointegration * systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * unable or unwilling to return for follow-up visits * bruxism or other parafunctional activity
gastric mucosal changes in patients with dermatomyositis

Conditions: Gastric Mucosal Manifestations in Patients With Dermatomyositis

Summary: there are a large number of reports in the literature that patients with dermatomyositis often have various malignant tumors, and reports of gastric cancer are not rare. at present, the widely recognized gastric cancer occurrence patterns are: normal gastric mucosa-chronic superficial gastritis-chronic atrophic gastritis-intestinal metaplasia-dysplasia-gastric cancer, so the research about the gastric mucosal performance of patients with dermatomyositis is clinically meaningful


Eligibility criteria:
inclusion criteria: * 1、18-70years old，no gender limit. 2、clinical diagnosis of dermatomyositis. 3、dermatomyositis group conform to 1 and 2，control group conform to 1 . exclusion criteria: * contraindications for gastroscopy. * past history of malignant tumors of the esophagus and stomach and or history of surgery. * pregnant or lactating women. ④ participated in other clinical studies within 3 months. ⑤patients cannot express their main complaints correctly and cannot cooperate with the research.
omega-3-acid ethyl esters 90 soft capsules for lowering very high triglycerides

Conditions: Hypertriglyceridemia

Summary: the trial was a double-blind, randomized, parallel-group study comparing omega-3-acid ethyl esters 90 soft capsules and placebo. the primary objective of the present study was to evaluate the efficacy and safety of omega-3-acid ethyl esters 90 soft capsules in subjects with severe hypertriglyceridemia (tgs ≥500 mg/dl but \<2000 mg/dl).


Eligibility criteria:
inclusion criteria: -1.at least 2 times of fasting serum tg concentrations≥500 mg/dl but\<2000 mg/dl at screening (2and 1 and 0 weeks before random assignment). 2.two times qualified high triglycerides dietary assessment table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in chinese adults guide ". exclusion criteria: * 1.unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study. 2.patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase. 3.subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study. 4.serum alanine aminotransferase (alt) or aspartate aminotransferase (ast)\>3 times the upper limit of normal. 5.serum creatinine \>176μmol/l. 6.platelet counts\ 11.1mmol/l). 9.type ii diabetes, nephrotic syndrome, hypothyroidism. 10.atrial fibrillation. 11.history of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy. 12.history of cancer (other than basal cell carcinoma) in the past 2 years. 13.allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish. 14.history in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary. 15.exposure to any investigational product, within 30 days prior to visit. 16.presence of any other condition the investigator believes would interfere the study.
strimvelis registry study to follow-up patients with adenosine deaminase severe combined immunodeficiency (ada-scid)

Conditions: Immunologic Deficiency Syndromes

Summary: adenosine deaminase (ada) enzyme deficiency results in severe combined immunodeficiency (scid), a fatal autosomal recessive inherited immune disorder. strimvelis (or gsk2696273) is a gene therapy intended for patients with ada-scid and for whom no suitable human leukocyte antigen (hla) matched related stem cell donor is available. this therapy aims to restore ada function in hematopoietic cell lineages, and in doing so prevents the pathology caused by purine metabolites (i.e., impaired immune function). this registry evaluates the long term safety and effectiveness outcomes of subjects who have received strimvelis (or gsk2696273).

this is a prospective, non-interventional follow-up registry of patients with ada-scid treated with strimvelis™. the registry does not have a comparator group and the product will have been given on a single occasion prior to entering this registry. safety and effectiveness will be assessed for a target number of 50 patients who will have received strimvelis™ (or gsk2696273) comprising patients treated prior to marketing authorisation (i.e. clinical studies and compassionate use programs) and those treated after marketing authorisation (including within compassionate use and early access programs). the registry will close to enrolment when 50 patients have been enrolled but will not close completely until the 50th patient finishes their 15 year follow-up.

Eligibility criteria:
inclusion criteria 1. patient with ada-scid, treated with strimvelis™ or gsk2696273, as part of its clinical development program. 2. adult patients, or patients for whom their parents or legal guardians have signed the informed consent form for participation in the registry. there are no formal exclusion criteria for participation as this registry will follow all patients who have received strimvelis™ prior to enrollment, subject to informed consent.

Keywords: gene therapy retroviral vector inherited immune disorder ada-scid previously gsk2696273 strimvelis
gefitinib in treating patients with newly diagnosed glioblastoma multiforme

Conditions: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Summary: biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. phase ii trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

objectives: i. determine treatment effectiveness of gefitinib, in terms of response rate, time to progression, survival at 52 weeks, progression-free survival at 6 months, and overall survival, in patients with newly diagnosed glioblastoma multiforme. ii. determine the toxic effects of this drug in these patients. iii. assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug. iv. assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients. v. determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug. outline: this is a multicenter study. patients receive oral gefitinib daily. courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. patients are followed every 8 weeks until tumor progression and then every 3 months for 5 years and annually for up to 10 years. patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. projected accrual: a total of 92 patients will be accrued for this study within 14 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed newly diagnosed who grade iv astrocytoma (glioblastoma multiforme) or gliosarcoma * no who grade iii anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma * completed standard external beam radiotherapy within the past 2-5 weeks * no evidence of tumor progression during radiotherapy * performance status - ecog 0-2 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10.0 g/dl * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast no greater than 3 times uln * creatinine no greater than 1.5 times uln * no other active malignancy * no uncontrolled infection * no other severe concurrent disease that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor * see disease characteristics * no prior stereotactic radiosurgery or interstitial brachytherapy * no more than 15 weeks since prior surgery